PROVAYBLUE Drug Patent Profile
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When do Provayblue patents expire, and what generic alternatives are available?
Provayblue is a drug marketed by Provepharm Sas and is included in one NDA.
The generic ingredient in PROVAYBLUE is methylene blue. There are twenty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methylene blue profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Provayblue
A generic version of PROVAYBLUE was approved as methylene blue by ZYDUS LIFESCIENCES on December 5th, 2023.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for PROVAYBLUE?
- What are the global sales for PROVAYBLUE?
- What is Average Wholesale Price for PROVAYBLUE?
Summary for PROVAYBLUE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 126 |
| Clinical Trials: | 2 |
| Drug Prices: | Drug price information for PROVAYBLUE |
| What excipients (inactive ingredients) are in PROVAYBLUE? | PROVAYBLUE excipients list |
| DailyMed Link: | PROVAYBLUE at DailyMed |
Recent Clinical Trials for PROVAYBLUE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Carilion Clinic | Phase 2 |
| Provepharm Life Solutions | Phase 2 |
| Provepharm SAS | Phase 4 |
Pharmacology for PROVAYBLUE
| Drug Class | Oxidation-Reduction Agent |
| Mechanism of Action | Oxidation-Reduction Activity |
US Patents and Regulatory Information for PROVAYBLUE
PROVAYBLUE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting PROVAYBLUE
INFORMATION ADDED TO THE CLINICAL STUDIES SECTION TO FULFILL A POST-MARKETING REQUIREMENT
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630-002 | Jul 18, 2019 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630-001 | Apr 8, 2016 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
